Ex Parte 6797286 et al

Board of Patent Appeals and Interferences

Apr 16, 2010

90007468 (B.P.A.I. Apr. 16, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte RAINFOREST NUTRITIONALS
____________

Appeal 2009-000983
Reexamination Control 90/007,468
Patent 6,797,286
Technology Center 3900
____________

Decided: April 16, 2010
____________

Before ERIC GRIMES, ROMULO H. DELMENDO, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the patent holder of U.S. Patent
No. 6,797,286 from the Patent Examiner’s rejections of claims 15 and 17-19.
The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and
306. We reverse.

STATEMENT OF THE CASE
A Request for Ex Parte Reexamination of claim 1 of U.S. Patent No.
6,797,286 (“the ‘286 patent”), issued Sep. 28, 2004, was filed by a third-
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party requester (“Requester”) on March 17, 2005, pursuant to 35 U.S.C. §§
302-307 and 37 C.F.R § 1.510 (“Request”). Reexamination was sought on
the basis of a prior art publication by Sheng (Sheng et al., “Treatment of
chemotherapy-induced leukopenia in a rat model with aqueous extract from
Uncaria tomentosa,” PHYTOMEDICINE 7(2): 137-143, 2000) which was said
not to have been considered by the PTO during examination of the
application which matured into the ‘286 patent (Request 2). The Requester
asserted that claim 1, drawn to an extract from Uncaria plant material, was
invalid under 35 U.S.C. § 102 and § 103 in view of Sheng (id. at 2). The
Request for Reexamination was granted. (Order Granting Ex Parte
Reexamination, May 5, 2005.) A detailed Office Action was subsequently
issued by the Patent Examiner, rejecting claims 1-14, all the claims of the
‘286 Patent. (Office Action 1, Oct. 7, 2005.)
After protracted prosecution in which various amendments were
made, and new claims added and then cancelled, Appellant canceled claims
1-14 of the ‘286 patent, leaving new claims 15, 17, 18, and 19 pending – the
only claims on appeal in this proceeding (Supplemental Amendment, May
22, 2009). Thus, the ‘286 patent claim 1, drawn to the Uncaria extract, was
cancelled. None of the remaining pending claims is to an extract; rather the
pending claims at issue in this appeal are to methods of producing a
composition derived from Uncaria.
Claim 15, the only independent claim on appeal, is to a method of
producing a composition that has anti-inflammatory and non-immuno
stimulating properties. The composition is produced from decocted plant
material of Uncaria tomentosa. The composition has a content of less than
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0.3 mg/g of oxindole alkaloids. Claims 17-19 depend on claim 15 and
incorporate all the limitations of claim 15.
According to the ‘286 patent, Uncaria, also known as Cat’s Claw, is
marketed and sold as an herbal medicine throughout the world (‘286 patent,
col. 1, ll. 26-27). It is said to have both immunostimulating and
immunosuppressant activity (id. at col. 1, ll. 43-48). The ‘286 patent states
that “Researchers have determined that Uncaria’s immunostimulating
actions are attributable to alkaloids, pentacyclic and oxindole, that are more
lipophilic than the . . . immunosuppressant components” (id. at col. 1, ll. 46-
48). The ’286 patent discloses that the “dichotomy between the
immunostimulatory (pro-inflammatory) alkaloids and the
immunosuppressive (anti-inflammatory) agents, concurrent yet opposing
actions - stimulation and suppression - limit the true potential and benefits of
either component.” (Id. at col. 2, ll. 18-22.) “Thus, a method of
distinguishing and removing from Uncaria decoctions the
immunostimulatory alkaloids would result in an Uncaria extract with
enhanced efficacy and therapeutic potential of the polar,
immunosuppressive, TNF-alpha inhibiting agents.” (Id. at col. 2, ll. 22-26.)
Claims 15 and 17-19 stand rejected by the Examiner as follows:
1. Claims 15 and 17-19 under 35 U.S.C. § 112, first paragraph, as
lacking a written description of a “non-immuno stimulating” composition as
recited in the claims (Ans. 3-4);
2. Claims 15 and 17-19 under 35 U.S.C. § 305 as enlarging the scope
of the claims of the ‘286 patent (Ans. 4);
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3. Claims 15 and 17-19 under 35 U.S.C. § 112, first paragraph, as
claiming subject matter which is not enabled by the Specification (Ans. 5);
and
4. Claims 15 and 17-19 under 35 U.S.C. § 103(a) as obvious in view
of Pero (U.S. Pat. No. 6,039,949, Mar. 21, 2000), Sheng, and Keplinger
(U.S. Pat. No. 5,302,611, Apr. 12, 1994) as evidenced by Sandoval
(Sandoval et al., PHYTOMEDICINE, 9:325-337, 2002) (Ans. 8).
Claim 15 is representative and reads as follows:
15. A method of producing a composition having anti-
inflammatory and non-immuno stimulating properties,
comprising:
decocting plant material from genus Uncaria, species
tomentosa, to resolve a decocted extract;
filtering the solid mater [matter?] from the decocted
extract;
combining the filtered decocted extract with an organic
solvent;
agitating the combination;
separating the combination into distinct phases to resolve
a genus Uncaria, species tomentosa, derived composition
comprising polar constituents and less than 0.3 mg/g of
oxindole alkaloids; and
evaporating the organic solvent to resolve the polar
components.

1. WRITTEN DESCRIPTION
Claims 15 and 17-19 stand rejected under 35 U.S.C. § 112, first
paragraph, as lacking a written description of a “non-immuno stimulating”
composition as recited in the claims (Ans. 3-4).
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Statement of the issue
Claim 15, drawn to a method of producing a composition from
Uncaria plant material “having anti-inflammatory and ‘non-immuno
stimulating’ properties,” was added by amendment during this
reexamination proceeding (Patentee’s Response, Jul. 5, 2007). The
Examiner contends that the recited term “non-immuno stimulating” was not
described in the Specification and therefore is “new matter.” (Ans. 4.) The
Examiner explained:
While “immuno stimulatory alkaloids” and
“immunosuppressive agents” have been described (column 2,
lines 15-26), there is no description in the specification for
“non-immuno-stimulating”, which may have the meaning of
immunosuppressive, no immunomodulatory effect, or the
immunostimulating effect has been offset by the
immunosuppressive effect etc.
(Ans. 4.)
“[A]n examiner can make out a prima facie case of lack of adequate
written description, thus shifting the burden of production to the applicant,
simply by identifying specific claim limitations and stating that despite
reviewing the specification, he could not find support for those limitations.”
Hyatt v. Doll, 576 F.3d 1246, 1274 (Fed. Cir. 2009). Therefore, the issue in
this appeal is whether Appellant rebutted the Examiner’s determination that
the claims contain subject matter which was not described in the ‘286 patent.

Principles of law
To satisfy the written description requirement, the inventor “must also
convey with reasonable clarity to those skilled in the art that, as of the filing
date sought, he or she was in possession of the invention.” Vas-Cath Inc. v.
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Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). In describing the
claimed invention, there is no requirement that the wording be identical to
that used in the specification as long as there is sufficient disclosure to show
one of skill in the art that the inventor “invented what is claimed.” Union
Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir.
2000). Thus, so long as a person “of ordinary skill in the art would have
understood the inventor to have been in possession of the claimed invention
at the time of filing, even if every nuance of the claims is not explicitly
described in the specification, then the adequate written description
requirement is met.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).

Facts
From the “Background of the Invention” of the ‘286 patent:
1. “Researchers have identified inherent immunostimulating as well as
immunosuppressant actions caused by the diverse chemical constituents of
the Uncaria species. Researchers have determined that Uncaria’s
immunostimulating actions are attributable to alkaloids, pentacyclic and
oxindole . . . .” (Id. at col. 1, ll. 44-49.)
2. “Related art exists for the extraction, concentration and determination of
Uncaria's lipophilic alkaloids extractions with higher alkaloid concentrations
(U.S. Pat. Nos. 4844901, 4940725, 5302611 [Keplinger], 5723625). The
method uses aqueous ammonia pretreatment followed by supercritical
extraction. The resultant material has been indicated for unspecific
stimulation of the immune system as characterized by increased macrophage
phagocytosis.” (Id. at col. 1, ll. 55-62.)
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3. “Related art also exists that teaches that a hot water extraction of the
crude plant parts of Uncaria and the subsequent dialysis of the solubilized
products yields a composition which has a high degree of the immune
stimulatory activities (U.S. Pat. Nos. 6039949 [Pero], 6238675, 6361805).
These activities were confirmed through increased lymphocyte phagocytosis
and cytokine production and more recently, increased vaccine response.”
(Id. at col. 1, l. 63-col. 2, l. 3).

From the “Summary of the Invention” of the ‘286 patent:
4. “The present invention describes an extract and method for extracting or
depleting from plants of the Uncaria species . . . it’s [sic] lipophilic,
immunostimulating alkaloids whilst retaining and then further concentrating
its polar, immunosuppressive agents . . . The resulting Uncaria extract is
substantially deplete[d] of immunostimulatory actives and retains enhanced
anti-inflammatory components and antioxidant capacities.” Id. at col. 2, ll.
26-36.)
5. “In contrast to its immunostimulating alkaloids, preparations or
decoctions of Uncaria plant material also exhibit an inherent
immunosuppressive and anti-inflammatory result. This dichotomy between
the immunostimulatory (pro-inflammatory) alkaloids and the
immunosuppressive (anti-inflammatory) agents, concurrent yet opposing
actions - stimulation and suppression - limit the true potential and benefits of
either component.” (Id. at col. 2, ll. 15-22.)
6. “Thus, a method of distinguishing and removing from Uncaria decoctions
the immunostimulatory alkaloids would result in an Uncaria extract with
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enhanced efficacy and therapeutic potential of the polar,
immunosuppressive, TNF-alpha inhibiting agents.” (Id. at col. 2, ll. 22-26.)

Analysis
When a claim is added during patent reexamination, the Examiner
must determine whether the claim is described in the patent as required by
the written description requirement of 35 U.S.C. § 112, first paragraph. The
purpose of § 112, first paragraph, in these circumstances is to ensure that the
inventor is not claiming an invention that he did not invent. The wording of
the claim does not have to be identical to the words in the patent. But the
patent must convey to the ordinary skilled worker that the inventor had
“possession” of the later claimed invention with all its limitations.
The Examiner determined that the written description of the ‘286
patent did not literally describe a composition with “non-immuno
stimulating properties” as recited in claim 15. The Examiner acknowledged
that the patent described “immunostimulatory alkaloids,” but found that it
could have the meaning of “immunosuppressive, no immunomodulatory
effect, or the immunostimulating effect . . . offset by the immunosuppressive
effect” and was thus not clearly defined (Ans. 7). The Examiner also
contends that a description is lacking because the Specification did not
provide data of a composition with “non-immuno stimulating properties”
(id. at 12-15).
When the Examiner determines that a specific limitation recited in a
later claimed invention is not expressly disclosed in the Specification, as she
did here, she can shift the burden to the applicant to produce evidence that
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such limitations are described by the Specification. Appellant met this
burden.
Uncaria compositions are described in the Background of the
Invention to have been known to possess “immunostimulating” activity (F1,
F3). This activity is expressly as characterized as “increased lymphocyte
phagocytosis and cytokine production” and “increased vaccine response.”
(F2, F3.) In the Summary of the Invention, the “present invention” is
described as an extract substantially depleted of its “immunostimulatory
actives.” (F4.) The ordinary skilled worker, upon reading the Specification,
would have understood that an extract depleted of “immunostimulatory
actives” lacks phagocytosis, cytokine, and vaccine activities and therefore
would be understood to be not immunostimulatory or “non-immuno
stimulating,” as recited in claim 15. Consequently, we find that the term
“non-immuno stimulating properties” is described in the ‘286 patent.
In support of her position, the Examiner argued that the ‘286 patent
did not provide sufficient data to establish that a composition with non-
immuno stimulatory properties had been invented (Ans. 12-15). Appellant
responded that the increased anti-inflammatory activity observed when the
alkaloids had been removed from the extract was evidence that the alkaloids
were immunostimulatory because “removal of the immunostimulating
alkaloids in Uncaria tomentosa removes the actives which ordinarily counter
or suppress the anti-inflammatory actives.” (Reply Br.1 4.) To support this
argument, Appellant cited a data table in the patent purporting to show

1 Reply Brief dated September 22, 2009.
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increased anti-inflammatory activity in depleted extracts (‘286 patent,
column 4, ll. 26-35, hereinafter, “table” or “column 4 table.”)
The Examiner rejected this evidence, asserting that the data was
“ambiguous and inconclusive” and inconsistent with data in the Sandoval
publication coauthored by the inventor (Ans. 13-14). Specifically, the
Examiner found that anti-inflammatory activity for the freeze-dried alkaloid
depleted Uncaria spp. as described in the column 4 table was the same value
(9.5 ng/ml) as reported for the standard, alkaloid undepleted extract, of
Uncaria guianensis described in the Sandoval publication (Ans. 13-14),
which apparently the Examiner believed made the data less credible.2
The ‘286 patent explains that, when alkaloids are depleted from the
Uncaria extract, the resulting composition “is substantially deplete[d] of
immunostimulatory actives and retains enhanced anti-inflammatory
components and antioxidant capacities.” (F4) The reason for the enhanced
anti-inflammatory is that “the immunostimulatory (pro-inflammatory)
alkaloids” oppose the anti-inflammatory components, “limit[ing] the true
potential and benefits of either component.” (‘286 Patent at col. 2, ll. 15-
22.) Thus, while no direct measurement of immunostimulatory activity was
made, Appellant provided a logical reason explaining why the observed
increase in anti-inflammatory activity was consistent with the absence of
immunostimulatory activity.
As to the equivalence between the anti-inflammatory activity for the
freeze-dried alkaloid depleted Uncaria spp. and the standard, alkaloid

2 The Examiner characterized the equivalence between the two values as
interesting (Ans. 13: “Interestingly”).
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undepleted extract, of Uncaria guianensis, Appellant pointed out that each
has only residual alkaloid activity and therefore it would be expected that the
anti-inflammatory activities would be the same due to the absence of the
opposing stimulatory effect (Reply Br. 5; 0.3 mg/g alkaloid in the ‘286
patent extract (col. 5, ll. 23-26); 0.26 mg/g alkaloid in Sandoval (p. 330,
Table 1)). The Examiner did not identify any deficiency in this reasoning.
The written description rejection of claims 15 and 17-19 is reversed.

2. REJECTION UNDER 35 U.S.C. § 305
Claims 15 and 17-19 stand rejected under 35 U.S.C. § 305 as
enlarging the scope of the claims of the ‘286 patent (Ans. 4).

Statement of the issue
Under 35 U.S.C. § 305:
In any reexamination proceeding under this chapter, the patent
owner will be permitted to propose any amendment to his
patent and a new claim or claims thereto, in order to distinguish
the invention as claimed from the prior art cited under the
provisions of section 301 of this title, or in response to a
decision adverse to the patentability of a claim of a patent. No
proposed amended or new claim enlarging the scope of a claim
of the patent will be permitted in a reexamination proceeding
under this chapter.
Original claims 6 and 13 of the ‘286 patent were method claims
reciting in their preamble, “extracting the lipidic components from plants of
the genus Uncaria” and “reducing the alkaloid content in an extract from
plants of the genus Uncaria,” respectively. The method steps of claims 6
and 13 are similar to those recited in newly-added claim 15. The preamble
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of claim 15, however, recites that it is a “method of producing a composition
having anti-inflammatory and non-immuno stimulating properties.” The
Examiner determined that the phrase “non-immuno stimulating properties”
was not described in the ‘286 patent and concluded that the “claims are
broadened by the introduction of new matter, which is not supported by the
[‘286 patent] specification or the original claims” (Ans. 5).
The issue in this rejection is whether the recited phrase “non-immuno
stimulating properties” improperly broadened the scope of the claims of the
‘286 patent.
Analysis
The only basis the Examiner had for rejecting the claims under 35
U.S.C. § 305 was that the phrase “non-immuno stimulating properties” was
not described in the ‘286 patent. As discussed in the previous section, the
written description of the ‘286 patent describes a composition with “non-
immuno stimulating properties.” Since the Examiner erred in this
determination, we reverse the rejection under section 305.

3. ENABLEMENT REJECTION
Claims 15 and 17-19 stand rejected under 35 U.S.C. § 112, first
paragraph, as claiming subject matter which is not enabled by the
Specification (Ans. 5).
Statement of the issue
The issue in this rejection is whether the ‘286 patent teaches how to
make a composition comprising less than 0.3 mg/g of oxindole alkaloids and
which has “non-immuno stimulating properties.”
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Principles of Law
“‘[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk, A/S,
108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557,
1561 (Fed. Cir. 1993)). “When rejecting a claim under the enablement
requirement of section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of protection
provided by that claim is not adequately enabled by the description of the
invention provided in the specification of the application; this includes, of
course, providing sufficient reasons for doubting any assertions in the
specification as to the scope of enablement . . . Marzocchi, 439 F.2d at 223-
24.” In re Wright, 999 F.2d at 1561-62.
In making an enablement determination, the following factors may be
considered: (1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of working
examples, (4) the nature of the invention, (5) the state of the prior art, (6) the
relative skill of those in the art, (7) the predictability or unpredictability of
the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737
(Fed. Cir. 1988).
Facts
Pero
7. Pero “teaches that if the plant species of Uncaria are hot water
extracted . . . and then dialyzed to deplete ubiquitous non-specific toxic
components and the levels of previously identified lipophilic components
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such as sterols and alkaloids possessing anti-tumor and anti-inflammatory
properties, there still remains in the dialyzable fraction a . . . preparation of
Uncaria having potent anti-tumor and immune stimulatory properties . . . .”
(Col. 2, ll. 35-44.)
8. The formulation “would likely have been depleted of many of the known
active ingredients of Uncaria, namely the sterols and alkaloids, because it is
a low molecular weight water soluble preparation.” (Id. at col. 2, ll. 46-49.)
9. After hot water extraction, the extract was “filtered through common
coffee filters,” and inter alia, “transferred into cellulose membrane dialysis
tubing (pore size 2.4 nm, exclusion limit=<12 000 molecular weight, KEBO
Lab) and dialyzed against” distilled water (id. at col. 4, ll. 39-47).
10. After dialysis, the high molecular weight fraction retained in the dialysis
tubing was discarded, and the low molecular fraction that had diffused out
was concentrated (id. at col. 4, ll. 48-53).
11. The low molecular weight fraction “is referred to as C-Med-100 extract”
(id. at col. 4, ll. 52-55).
12. Example 7 of Pero “discloses the immune stimulating properties of C-
MED-100 extract supplemented in vivo . . . . Splenocytes from the C-MED-
100 treated rats had an enhanced ability to respond to the growth stimulation
induced by the mitogen, PHA.” (Id. at col. 8, ll. 4-10.)

Sheng
13. Sheng, which includes Pero as a co-author, teaches “Uncaria tomentosa
water extracts (C-Med-100®) depleted of indole alkaloids (< 0.05%, w/w)
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have been shown . . . to enhance DNA repair, mitogenic response and white
blood cells in vivo.” (Summary, p. 137).
14. Appellant does not dispute that “0.05% w/w” is 0.5 mg/g. (Ans. 9.)
15. “The mechanism of the C-Med 100® effect on WBC is not known but
other data showing enhanced effects on DNA repair and immune cell
proliferation response support a general immune enhancement.” (p. 137.)

Keplinger
16. Keplinger discloses “that oxindole alkaloids of the formula C12H24O4N2
. . . form a further group with immunostimulating properties.” (Col. 2, ll.
44-46.)
17. Keplinger teaches that “pentacyclic oxindole alkaloids . . . are suitable
for the unspecific stimulation of the immunologic system” which causes an
increase in phagocytosis activity (id. at col. 3, ll. 12-21).
18. Keplinger describes preparing extracts with the oxindole alkaloids as
follows (id. at col. 12, ll. 8-23):
19. • moisten dried Uncaria tomentosa with NH3;
20. • macerate with ethyl acetate;
21. • concentrate and extract with H2SO4;
22. • mix aqueous phase with Na2CO3; and
23. • “By means of repeated extraction of the aqueous phase with ethyl
acetate . . . the drug became 6.75 g of a light brown colored raw alkaloid
mixture.” (Id. at col. 12, ll. 18-21.)
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24. Keplinger disclosed that extracts with “low alkaloid amounts, did not
show a high phagocytosis activation in the case of average increase rates
between 10% and 20%.” (Id. at col. 19, ll. 6-29.)

Sandoval
25. “Oxindole alkaloids have been touted as the active ingredients in cat’s
claw based on an immunostimulatory action (. . . Keplinger et al., 1999
. . . ).” (Col. 2, p. 334.)
26. “Several problems exist with this connection.” (Id.)
27. “First, few studies have demonstrated that alkaloids possess the same,
but enriched, bioactivity as the parent botanical, cat’s claw. While the
oxindole alkaloids may indeed promote phagocytosis, there is lack of
evidence linking this action to the in vivo or in vitro actions of cat’s claw.”
(Id.)
Analysis
Claim 15 is drawn to a method of producing a composition from
Uncaria tomentosa which has “less than 0.3 mg/g of oxindole alkaloids” and
which possesses “anti-inflammatory and non-immuno stimulating
properties.” The Examiner contends that ‘286 patent attributes the lack of
immunostimulatory activity to reduced levels of oxindole alkaloids, but did
not provide evidence of this association. The Examiner cited contrary
evidence that Uncaria extracts depleted of oxindole alkaloids possess
immunostimulatory activity, establishing a “high degree of unpredictability
in the art.” (Ans. 6.) Based on this reasoning, the Examiner determined that
the Specification does not enable a composition extracted from Uncaria that
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has “non-immuno stimulating properties” and “less than 0.3 mg/g of
oxindole alkaloids.”
Contrary to the Examiner’s contention, the Specification does contain
evidence of a composition having “non-immuno stimulating properties” with
the claimed levels of oxindole alkaloids. As discussed above with reference
to the column 4 table (supra at p. 10, the Specification describes an example
of an alkaloid-depleted extract which is characterized in the ‘286 patent as
having “superior” activity to preparations having higher alkaloid contents
(‘286 patent, col. 4, ll. 26-38 & 51-62). Appellant attributes this result to the
“removal of immuno-stimulating alkaloids . . . which ordinarily counter or
suppress the anti-inflammatory activity.” (Reply Br. 4.)
The Examiner considered this data inconclusive because “the oxindole
alkaloid contents of the 3 extracts are not specified.” (Ans. 7.) It is true that
the table at column 4, listing the activity of the three extracts, does not
include information about the oxindole alkaloid content. However, the ‘286
patent states, with reference to the column 4 table, that the “[anti-
inflammatory] potency was significantly greater in alkaloid depleted freeze-
dried formulation when compared to the other formulations (P<0.01).”
(‘286 patent, col. 4, ll. 23-25; see also col. 4, ll. 55-59.) Therefore, the data
in the table at column 4 is consistent with Appellant’s assertion that
depleting alkaloids enhances anti-inflammatory activity because of the
absence of the immunostimulatory component.
As to the amounts of oxindole alkaloids, the ‘286 patent discloses
“that the oxindole alkaloid content of the Uncaria extracts processed as
described herein is less than 0.3 mg/g of dired [sic, dried] decoction.” (Id. at
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col. 5, ll. 23-25.) Persons of ordinary skill in the art would therefore have
recognized that the alkaloid depleted freeze-dried processed formulation
listed in the column 4 table comprised less than 0.3 mg/g oxindole, the
quantity required by claim 15.
The ’286 patent also discloses the starting concentrations of the
oxindole alkaloids: “Normal or starting detected values of oxi[n]dole
alkaloid content are 9 mg/g of decoction or 1.8 mg/g of raw botanical. The
extraction procedure reflects a depletion of at least 30 fold resulting in an
almost undetectable quantity of oxi[n]dole alkaloids.” (Id. at col. 5, ll. 27-
32.)
In sum, while the Examiner was correct that the column 4 table did
not disclose the oxindole alkaloid amounts, there is adequate information in
the ‘286 patent to determine that the “Freeze-dried Alkaloid Deplete
Uncaria” listed in the table meets the claimed limitation as far as its oxindole
alkaloid concentration, and that it also contains less alkaloid that the other
two formulations, but possesses more anti-inflammatory activity.
The Examiner contends that to comply with § 112, first paragraph, it
was necessary to have directly determined the immunostimulatory activity in
the alkaloid depleted Uncaria extracts because it would have been
unpredictable that an extract depleted in alkaloids, as claimed, would lack
such activity. To support this position, the Examiner cited Pero’s teaching
of a hot water extract “dialyzed to deplete . . . sterols and alkaloids,” but
which still had “immune stimulatory properties” (F7, F8). That is, the prior
art taught a composition, depleted of alkaloids, but which retained its
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immunostimulatory properties, in contrast to the claimed alkaloid depleted
composition which is non-immunostimulatory.
Pero’s disclosure is not inconsistent with the subject matter of claim 1.
Pero described an Uncaria extract referred to as C-Med-100. The inventor,
Mr. Paul Bobrowski, testified that certain alkaloids have a molecular weight
of less than 500 and thus “would not be significantly and or reliably filtered
by a dialysis procedure designed to remove substances having a molecular
weight greater than 10,000 (>10,000MW)”3 (Declaration of Paul J.
Bobrowski, ¶ 16, dated Jul. 28, 2005). Among the alkaloids listed by Mr.
Bobrowski as having a molecular weight of less than 500 are five alkaloids
of the chemical formula C21H24N2O4 (id. at 15), the same formula described
by Keplinger as representing oxindole alkaloids (F16). Taken together, the
evidence supports the finding that Pero’s C-Med-100 extract would contain
oxindole alkaloids, the same components described in the Keplinger to have
immunostimulatory properties (see App. Br.4 25). In other words, Pero’s
extract said to be depleted of “sterols and alkaloids” still contained oxindole
alkaloid and therefore would have been expected to possess immune
stimulatory properties.
In addition, as argued by Appellant, Pero’s C-Med-100 extract was
said to comprise less than 0.5 mg/g alkaloids, which permits a higher
alkaloid content than the claimed extract.

3 The exclusion limit was actually 12,000 (F9).
4 Appellant’s (1st Corrected) Brief, dated Jul. 1, 2009.
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In sum, Appellant’s description of a “non-immuno stimulatory”
extract depleted of oxindole alkaloids is not inconsistent with Pero’s
teaching.
The Examiner also determined that Sandoval was inconsistent with
claims to an alkaloid-depleted composition which was non-
immunostimulatory because Sandoval (which included the inventor Mr.
Bobrowski as a co-author) noted the “lack of evidence linking oxindole
alkaloids to immunostimulation.” (Ans. 17.)
This argument is not supported by Sandoval. Sandoval, in fact,
recognizes that “oxindole alkaloids may indeed promote phagocytosis,” an
immunostimulatory activity (F27). However, the publication acknowledges
that this activity may not be responsible for the actions of cat claw herb,
itself (id.), i.e., when the whole herb is administered, rather than an extract
or composition with enhanced or increased amounts of the “oxindole
alkaloids.”
The enablement rejection of claims 15 and 17-19 is reversed.

4. OBVIOUSNESS
Claims 15 and 17-19 stand rejected under 35 U.S.C. § 103(a) as
obvious in view of Pero, Sheng, and Keplinger as evidenced by Sandoval5
(Ans. 8).

5 The Examiner cited Sandoval in the grounds of rejection, but appeared to
rely on it only in the rejection of claim 17 for its disclosure of oxindole
alkaloid content (Ans. 10). Appellant attempted to eliminate the Sandoval
publication as prior art “as it was not the work of another nor prior to the
invention by Mr. Bobrowski” (App. Br. 22). The Examiner did not find the
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Statement of the issue
Claim 15 comprises five steps for “producing a composition having
anti-inflammatory and non-immuno stimulating properties”: “decocting
plant material from genus Uncaria, species tomentosa;” filtering; combining
with an organic solvent; agitating; separating into phases; and evaporating
the solvent. The Examiner found that Pero taught the decocting and filtering
steps, but not using an organic solvent (Ans. 9.) However, the Examiner
found that Keplinger taught using an organic solvent to remove undesirable
alkaloids from a plant extract (id.). Based on this teaching, the Examiner
reasoned that it would have been obvious to a person of ordinary skill in the
art to have applied Keplinger’s extraction method to Pero’s decoction as “an
alternative effective method for depleting toxic lipidic alkaloids in a water
soluble extract from Uncaria tomentosa” (Id.).
Appellant argues “[a]ll the claims of the present patent require an
Uncaria tomentosa extract that is non-immunostimulating . . . Pero, Sheng,
and Keplinger each teach the manufacture and use of an Uncaria extract
made for and intended for immunologic stimulation.” (App. Br. 23.)
Appellant contends that Pero’s dialysis method would not exclude oxindole
alkaloids because of their low molecular weight, and therefore would not
contain less than 0.3 mg/g as required by claim 15 (id. at 25).

declaration persuasive because it did establish “that the Mr. Bobrowski is the
sole inventor and that the others were merely working under his direction, or
that the authors of the publication derived their knowledge from Mr.
Bobrowski. MPEP 715.01.” (Ans. 19.) The Examiner’s reasoning is
correct. However, as Sandoval was not relied upon in rejecting independent
claim 15, whether or not it was prior art to the claim does not affect our
analysis.
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The issue in this rejection is whether it would have been obvious to
persons of ordinary skill in the art to have combined the teachings of Pero,
Sheng, and Keplinger to produce a composition which comprises “less than
0.3 mg/g of oxindole alkaloids” and which possesses “non-immuno
stimulating properties.”
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co. of Kansas, 383 U.S. 1,
17 (1966).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability.” Id. at 417.
If a technique has been used to improve one device, and a
person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.
Sakraida and Anderson’s-Black Rock are illustrative—a court
must ask whether the improvement is more than the predictable
use of prior art elements according to their established
functions.
Id.
Finally, Baxter argues that the unexpected hemolysis-
suppression quality of DEHP rebuts any prima facie showing of
obviousness. However, when unexpected results are used as
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evidence of nonobviousness, the results must be shown to be
unexpected compared with the closest prior art. In re De
Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Here, the closest
prior art was the Becker system, utilizing a DEHP primary bag.
Mere recognition of latent properties in the prior art does not
render nonobvious an otherwise known invention. In re
Prindle, 297 F.2d 251, 254 (CCPA 1962). Since the prior art
bags plasticized with DEHP were inherently suppressing
hemolysis, albeit unknown at the time of the Becker document,
this hemolysis-suppressing function is not a basis for rebutting
a prima facie finding of obviousness
In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).

Claim interpretation
The preamble of claim 15 recites that the method is for “producing a
composition having anti-inflammatory and non-immuno stimulating
properties.” We do not interpret the claim to require that the method be
practiced with the intent to produce a composition with the recited properties
because intent or recognition that a method achieves a stated result does not
change how the method is carried out. However, as the method steps are
recited to be for producing a composition with “anti-inflammatory and non-
immuno stimulating properties,” we interpret the claim to require the
“derived composition” to possess those properties.
The term “non-immuno stimulating” is not expressly defined in the
Specification. However, the Specification discloses that “immune
stimulatory activities” include “increased lymphocyte phagocytosis and
cytokine production and more recently, increased vaccine response.” (F3.)
The prior art further discloses that an “immune stimulating” property
includes stimulating white blood cell proliferation (F15). Consequently,
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giving the term its broadest reasonable interpretation as it would be
understood by one of ordinary skill in the art, we interpret the claimed “non-
immuno stimulating” composition to be depleted of its activity in increasing
phagocytosis, cytokine production, a vaccine response, and white blood cell
proliferation.
Analysis
Both prior art methods relied upon by the Examiner in setting forth
the basis of the obviousness rejection produce a composition with
immunostimulatory properties. C-Med-100, described in the Pero and
Sheng publications, stimulates white blood cell proliferation (F12, F13, &
F15), an activity that persons of ordinary skill in the art would have
characterized as immunostimulatory. Testimony by the inventor, Mr. Paul
Bobrowski, established that persons of ordinary skill in the art would have
recognized that C-Med-100 would contain oxindole alkaloids because these
alkaloids would not have been excluded by the dialysis membrane used to
prepare C-Med-100. Keplinger’s composition comprises oxindole alkaloids
which produce an increase in phagocytosis activity (F16, F17), an activity
that also would have been recognized as immunostimulatory. Taking Pero’s
filtered decoction comprising oxindole alkaloids and then extracting it with
Keplinger’s organic solvent would not have reasonably been predicted to
produce a “non-immuno stimulating” composition since both methods were
utilized to prepare a composition that stimulated the immune response.
Because the application of Keplinger’s solvent extraction technique to
Pero’s filtration method would not have reasonably been expected to result
in a composition without immunostimulatory properties as claimed, we
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conclude that the combination is not a “predictable use of prior art elements
according to their established functions.” KSR, 550 U.S. at 416. The
claimed method produces a composition with non-immuno stimulatory
activity, a property which was not possessed by the compositions produced
by either prior art method, and therefore is an adequate basis to establish
patentability. In re Baxter, 952 F.2d at 388.
The obviousness rejection of claims 15 and 17-19 is reversed.

REVERSED

rvb

Patent Owner

VENABLE, CAMPILLO, LOGAN & MEANEY, P.C.
1938 E. Osborn Road
Phoenix, AZ 85016-7234

Third Party Requester

Michael A. Adler
DAVIDOFF MALITO & HUTCHER LLP
605 Third Avenue
New York, NY 10158